FDA OKs Catheters
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CardioVascular Dynamics Inc. said Monday it received U.S. Food and Drug Administration clearance to market its Guardian catheters.
The Irvine company, which develops medical devices, said the catheters treat atherosclerosis, which blocks blood flow within coronary arteries. The devices feature a multi-diameter balloon technology designed to perform intervention procedures using low and high balloon inflation pressures on a catheter.
During conventional balloon angioplasty, the company said, the dilatation force required to treat atherosclerosis is distributed over the entire length of the balloon, which affects the diseased site as well as adjacent vessel walls.
According to the company, Guardian catheters are designed to avoid damaging healthy vessel walls by focusing dilation force on diseased areas.
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